Pernasal application of aerosol medication

ABSTRACT

The invention shows means for holding a cylindrical medicine expansion chamber and spaced from it a cylindrical body having a nipple. The medication chamber has a mask which will just fit over a baby&#39;s nose with very little clearance. The medication chamber and the bottle are received in a holder having front and back walls, and set screws to push the medication holder and bottle against the adjoining walls.

This application is a continuation of application Ser. No. 08/939,283filed Sep. 29, 1997.

BACKGROUND OF THE INVENTION

Aerosol medications of all kinds are used to treat lung diseases or usethe lung as a portal of entry to treat systemic disease. One of the mostimportant conditions for which aerosols are used commonly is asthma, acondition for which first line therapy is inhaled beta₂-agonistbronchodilators and inhaled steroids. Asthma is a very common conditionin babies and infants, more common than in older children or adults.However, most devices for administering aerosol medication to babies arederived from those developed initially for delivery of asthma medicationto adults and older children. Most, if not all, such devices, whetherliquid nebulizers or designed for use with metered dose inhalers (MDIs)include the use of masks covering the mouth and the nose for thedelivery of the medication. However, recent studies have shown by meansof radiolabelled medication of aerosol delivery to the lungs, that theuse of current masks is inefficient with newborns and other very younginfants, most of the medication being deposited on the infant's face.Furthermore, babies tend to object to having a face mask firmly appliedto their face and often begin to cry. These factors greatly decrease theefficiency of aerosol medication delivery to their lungs.

If a nebulizer and face mask are used to provide inhaled aerosols to aspontaneously breathing infant, it is vital that the mask be snuglyattached to the face to insure adequate delivery. Studies have shownthat with liquid nebulization even a 1 centimeter distance from the facedecreases the dose delivered by 50 percent or more. Furthermore,nebulizers in infants tend to have the same disadvantages as in olderchildren, namely, high cost, need for a power supply, lack ofportability, complexities of assembly, loading and duration ofadministration. Infants are not very patient and do not like to sitstill for prolonged periods of 10 to 20 minutes usually required fornebulization of liquid solutions. This makes the MDI with a valvedholding chamber and mask the delivery system of choice in this agegroup.

The addition of a face mask to conventional valved holding chambers hasgained considerable acceptance from practitioners for the treatment ofinfants. However, it is recognized that the presently available devicesare less than ideal because infants do not readily accept the face mask“at least initially”. For infants up to the age of about two years themask must remain on the face tightly for at least three to six breaths,approximately 20 to 30 seconds, which may be difficult to achieve with asquirming and often crying infant at least until he gets used to it.

Infants prefer to breathe through the nose until at least 18 months ofage and are easily capable of sucking from the breast or bottle whilebreathing normally. Sucking is a very soothing activity for most babies.Sucking is performed during feeding or as a pacifier. We have designeddevices that will allow a combination of sucking activity of the babywhile at the same time ensuring that medication is delivered to therespiratory tract of the infant while the infant is relatively content.The devices are comprised of a 145 milliliter widely used valved holdingchamber attached to a nasal mask (aerochamber).

Alternatively the holding chamber may not have an integral valve, butboth its inhalation and exhalation valves could be contained within themasks. When the baby sucks on the bottle or soother, the mask is pulledtightly onto the nose, and surrounds the nostrils of the baby, whichensures that the aerosol that has been sprayed into the holding chamberwill be drawn into the baby's lungs with each breath through the noseduring approximately 20 seconds (five to six breaths). A mask andholding chamber would have an attachment that would extend downwardsaround the baby bottle or come onto the nipple so that any feedingbottle or nipple could be used. A set screw would allow the bottle to beadjusted in such a manner that the nasal mask would fit snugly, butwithout undo pressure around the infant's nostrils when the nipple ofthe bottle or soother is being sucked on vigorously. The resultingself-administered (but caregiver facilitated) seal between the mask andthe face around the nostrils would provide an excellent opportunity foractuation of the metered dose inhaler into the aerosol holding chamber,and delivery of the medication when the baby inhales duringapproximately five or six breaths.

Most babies and infants are obligatory nose breathers most of the time(with the exception of infants with nasal obstruction due to the commoncold, etc., or while crying) and it is therefore more logical toemphasize the nasal route for inhalation when devising an MDI accessoryaerosol delivery system. Indeed, even when a face mask is used, theaerosol is actually inhaled most of the time through the nose. The facemask thus has a much larger dead space than necessary, which insituations of low tidal volume such as in neonates or infants canconsiderably reduce the efficiency of delivery of aerosol medication. Asmall mask that preferentially directs the aerosol towards the infant'snose is thus superior to a face mask. Furthermore, aerosol delivered bymeans of a face mask must pass across the lower half of the face to getto the nostrils. Much of the steroid is thus actually delivered to theskin of the face, and there have been case reports of steroid sideeffects such as acne under these conditions. By using a nasal mask or asystem that directs the aerosol towards the nose, this problem would beminimized or eliminated since the aerosol would pass directly into thenares and from there into the lungs.

By way of background, inhaled therapy is the main,stay of asthmamanagement. Traditionally, most inhaled medication has been delivered bysmall volume wet nebulizers which are relatively bulky, expensive andnot always available when needed because of limited to theirportability. Metered dose inhalers are much more efficient, convenientand less expensive. The main problem with “press and inhale” metereddose inhalers is a need to coordinate aerosol discharge and inhalation.This problem has been solved in recent years by valved holding chambersthat can be filled with aerosol from which the patient inhales, and thusreceives medication. These devices disassociate aerosol delivery intothe aerosol holding chamber from inhalation, and so improve thereliability of aerosol administration. The use of a one way valve systemprovides for inhalation from the aerosol holding chamber during normalbreathing followed by exhalation via another valve in the mask. Thispermits aerosol to be delivered to infants and children during tidalbreathing provided that an appropriate mask is used to seal theinnerface between the aerosol delivery system and the infant's facearound the mouth and nose. This system works very well with olderchildren and adults who can be taught to inhale by mouth. However, it isless effective with neonatals and newborns who preferentially breathethrough the nose.

SUMMARY OF THE PRESENT INVENTION

It is the principal object of the present invention to utilize a nasalmask with an existing aerochamber The nasal mask directs the aerosol ofmedication droplets or dry particles to the nose and thus does notdeposit medication on parts of the face remote from the nose. It alsohas the smallest total mask volume and thus smallest dead space of anyinhaler system used for delivering medication to infants.

Furthermore, it is an object of the present invention to provide anadapter for holding a nasal applicator, and for also holding a bottle ofmilk or water or infant soother (rubber or plastic nipple) to ensurethat the nasal mask is applied by the sucking activity of the infant (asoothing activity for a young child).

The nasal mask which we use is attached to an aerosol holding chamberhaving a volume of 25 milliliters to 250 milliliters. There is aninspiratory and expiratory valve integral to the mask or to the device,or there may be an inspiratory valve on the holding chamber and anexpiratory valve as an integral part of the nasal mask to insure thatthe aerosol is delivered to the infant on inspiration only. The nasalmask would have an important advantage of greatly reducing the volume ofthe mask dead space, compared to the usual face mask (from about 15 to50 milliliters, to about 5 to 10 milliliters) and so improve aerosoldelivery efficiency. This is very important for improving aerosoltherapy in infant patients. An additional advantage that would beextremely important to the patient is the combination of the nasal maskfor aerosol delivery with an infant bottle and rubber nipple, orsoother, so that when the infant sucks the nasal mask is applied firmlyto the face around the nose. Infants up to the age of about 18 monthsare virtually obligatory nose breathers, so the aerosol would bedelivered efficiently to a relatively contented child. It has been shownthat if the infant is presented with aerosolized medication while it iscrying, virtually none of the drug gets to the lungs. By contrast, ifthe child is breathing quietly and is comfortable the aerosol deliveryto the lungs is relatively efficient.

To these ends, the principle of exclusively nasal administration ofaerosolized medication is combined with a technique for the child tosuck while breathing the medication. All of the possible permutationsand combinations such as the use of a bottle with liquid in it and arubber nipple, or even the possibility of breast feeding while the nasalmask is applied to the nose, are to be considered. Alternatively, asoother could be clamped to the nasal mask.

Furthermore, the invention is applicable to the use of either wetmedication, or dry, powdered medication.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The present invention will best be understood with reference to thefollowing drawings when taken in connection with the ensuingspecification, wherein:

FIG. 1 is a elevation side view, partially end in section, showing theuse of the mask with a holding chamber and also a bottle of milk orwater;

FIG. 2 is an end elevation view taken along the lines 2—2 in FIG. 1;

FIG. 3 is a view in perspective of the holding device for the mask and abottle;

FIG. 4 is a side elevation view similar to FIG. 1 showing the nasal maskas used with breast feeding;

FIG. 5 is an end elevation view taken from the left side of FIG. 4,showing how the device would be oriented with breast feeding;

FIG. 6 is a side elevation view of an alternative embodiment of theinvention;

FIG. 7 is an end elevation view of the embodiment of FIG. 6 viewed alonglines 7—7 in FIG. 6; and

FIG. 8 is a side elevations view of a self-contained nipple.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference first should be had to FIGS. 1-3, wherein there is shown atypical embodiment of the present invention. The device shown includes aholder 10 for two vessels. The holder 10 includes devices for securing aholding chamber 12 and a bottle 14. The holding chamber 12 may be builtalong the lines taught by Nowacki, et al., in U.S. Pat. No. 4,470,412and includes an inhalation valve at the exit end of the structure. Thedevices are all applied to a baby or infant 16 having a nose 18 and amouth 20.

The bottle 14 may be of uniform diameter and cylindrical, and has at theexit end a nipple 22 intended to be held in the mouth of the child.Aligned holes 24 and 26 are provided in the exit and entrance walls ofthe holder 10 which is shown as being of rectangular construction.O-rings 28 and 30 fit in these holes to receive the bottle 14. TheseO-rings provide a loose fit for the bottle 14, and a set screw 36 bearsagainst the side of the bottle to clamp it in place, taking up the loosefit of the O-rings 28 and 30.

Above the openings for the bottle there are openings 38 and 40 in theend walls of the rectangular holder 10. O-rings 42 and 44 are receivedin the holes 38 and 40 to provide a loose fit for the chamber 12, whichis adapted to receive the medication. The O-rings 42, 44 receive thebody of the chamber 12, which is cylindrical in shape, and a setscrew 46bears against the side of the chamber 12 to hold it in the O-rings.

At the inlet of the chamber 12 there is a universal back 48 made ofrubber and adapted to receive an L-shaped fitting 50, as shown in FIG.1. The fitting 50 is configured to carry a replaceable MDI 52 (MeteredDose Inhaler). The Metered Dose Inhaler contains a certain amount ofasthma medication, and when one pushes down on the MDI a metered dose ofaerosolized medication is discharged into the interior of the chamber12, The MDI may be of the type that holds a liquid droplet aerosol, orit may be designed to contain a dry powder. The chamber 12 is largeenough that the medication is thoroughly dispersed with the air withinthe chamber before it is inhaled.

At the exit end of the chamber 12 there is a nasal mask in the form of acup-shaped housing 54 which fits over the nose 18 of the infant,preferably leaving little room around the nose to minimize the deadspace of the mask, as discussed above, This results in efficient aerosoldelivery, yet there is very little exposed skin which can be contactedby the medication dispensed by the chamber 12. Most of the medicationthus enters the infant's nose directly and much more of it is depositedin the infant's or baby's lungs, thereby greatly improving theefficiency of the device. Also, there is much less chance of steroideffect on the skin as so little skin is exposed to the drug particles.

Referring to FIGS. 4 and 5, the holder 10 may be used without changeeven while the baby is nursing at the mother's breast 98 with a nipple58 inserted in the baby's mouth. It is only necessary to pivot thedevice a few degrees about the chamber 12 to retain a good fit of themask 54 on the baby's nose, with the bottle 14 pivoted somewhat awayfrom the mother's breast. The bottle 14 may either remain in place inits holder, as shown, or it may be removed from the holder 10 prior touse of the device with breast-feeding. Whether the baby is receivingmilk from the mother's breast, or milk or water from a bottle, or evensucking on a rubber or plastic nipple, such as from a pacifier, she willbe soothed. She will not be frightened or in an anxious state from themask 54 (which receives medication from the chamber 12 placed over hernose. As such, in contrast to current devices, the invention will allowthe baby to almost certainly tolerate the 20 seconds of drugadministration (5-6 breaths) and, therefore, is more likely to improveasthma control or provide relief from an asthma attack.

It will be understood that the mask 54 may be supplied in differentsizes and possibly shapes to accommodate the nose of any babyimaginable, and said nipples may also occur in different sizes fordifferent size children.

Another embodiment of the invention makes use of a nipple actually builtinto the mask. In an alternative construction of the invention, the maskis still applied to the face (as with current nose/mouth masks) but aninner mask configured to fit around the nose is located within the outermask, The soother can be molded into the rim of the mask, becoming apermanent part of it. Alternatively, an opening in the mask rim wouldallow the nipple of the baby bottle to be inserted to provide milk (orwater) while sucking. This would pull the mask towards the infant's faceand form a seal against the skin (aided if necessary by the mother orother caregiver).

With reference to FIGS. 6 and 7, one possible construction according tosuch alternative embodiments includes an aerochamber 82 in communicationwith a source of medication 84 and a face mask 60. An outer molded partof the face mask 60 is provided with an integral socket 80 designed tohold the aerochamber 82, the latter having an L-shaped fitting toreceive an MDI (metered dose inhaler) 84. The face mask 60 supports anasal mask 78 which is adapted to be placed over a baby's nose withoutsurrounding the baby's mouth, The face mask 60 is molded rubber orplastic and is shaped as an oval funnel (i.e., it is higher than it iswide) designed to fit over both the nose and mouth of a baby or infant.

The nasal mask 78 will flex up and down to a limited degree to ensurethat it is a proper fit on the nose due to the rubber or plastic natureof the material of the molding 68, while the rim of the molding sealsout the ambient air. The nasal mask 78 operates the same as the nasalmasks 12, 54 described above.

At a lower part of the face mask 60 is a portion 64 configured andshaped to hold a nipple 66 with the tip 68 of the nipple in the baby'smouths The nipple 66 will act as a pacifier and has a flange 74 (FIG. 7)coupled to the mask portion 64. The nipple 66 also has a bulbous part 72disposed opposite the tip 68 and received in the mask. In an alternativearrangement (not shown), the nipple 66 may be attached to a baby bottleby the bulbous part 72 of the nipple (FIG. 7) and the flange 72. Adouble (or split) wall 74 extends against the bottom of the nipple toinsure resistance to sucking on the nipple.

In use, the small mask 78 is designed to just fit over the baby's orinfant's nose and will be pulled in to form a very close fit with thenose upon inhalation. The outer molded part of the face mask is providedwith an integral socket 80 designed to hold an aerochamber 82, having anL-shaped fining to receive an MDI (metered dose inhaler) 84. The nasalmask 78 will flex up and down to a limited degree to ensure that it is aproper fit on the nose due to the rubber or plastic nature of thematerial of the molding, while the rim of the molding seals out theambient air, The face mask 78 operates the same as the face mask 54 todeliver medication to the baby's nose during inhalation.

FIG. 8 illustrates a design for a self-contained nipple 86 which canserve either of two purposes in the invention. The nipple 86 can be usedindependently of the mask, or it can be positioned anywhere on the maskand used without a bottle attached to it.

For example, in the embodiment of FIG. 6, the nipple and the bottle maybe considered to be a bit crowded. The mask may be partly cut away toleave room for positioning the nipple, or the mask may be omitted bymothers who have skilled hands. The nipple 86 in FIG. 8, which is notattached to a bottle and is completely self-contained, has its baseclosed off by a flange or wall 88 having a hole 90 into which a cork 92(either real or synthetic) is inserted to close off the milk-holdingportion 92 of the nipple. A few ccs of milk can be stored in the portion92 of the nipple, which is a sufficient amount to allow a baby to nursewhile taking medication. Either mask 54 or 80 is applied to the infant'sface or nose independently of the nipple 86 to allow such nursing, orthe nipple 86 can be coupled to any area of the mask, as describedabove.

It will be noted that, as used in the claims, the term aerosolizedmedication encompasses both wet and dry medications. The particularforms and embodiments of the invention shown herein are for illustrativepurposes only. Various changes will occur to those skilled in the artand will be understood as forming a part of the present inventioninsofar as they fall within the spirit and scope of the appended claims.

The invention is claimed as follows:
 1. A method for deliveringmedication to a human infant or baby while allowing the infant or babyto use a soother device, the method comprising steps of: (a) providing anasal mask sized and configured to be placed over an infant's nosewithout surrounding the infant's mouth, the nasal mask being adapted tobe placed in communication with a source of medication; (b) providing asoother device adapted to be sucked on by an infant; (c) placing thenasal mask over the infant's nose; (d) placing the soother device in theinfant's mouth; and (e) delivering medication to the nasal mask to allowthe infant to breathe in the medication through its nose while suckingon the soother device.
 2. The method of claim 1, wherein as a result ofstep (d) the infant sucks on the soother device and pulls the nasal maskagainst the infant's face to form a substantially sealed space toreceive the medication.
 3. The method of claim 2, wherein steps (c) and(d) are performed simultaneously.
 4. The method of claim 1, wherein step(a) is performed by providing a nasal mask comprising a chamber adaptedto receive medication, and step (e) is performed by coupling the chamberto a metered dose inhaler.
 5. The method of claim 4, wherein step (e) isperformed by delivering asthma medication to the chamber of the nasalmask.
 6. The method of claim 1, wherein the nasal mask is placedaccording to step (c) to form a sealed space having a volume in therange of from about 5 to about 10 milliliters.